Covid19NCT04524715
LLLT Treatment of Lung Inflammation in COVID-19
A study testing Non-invasive red LLLT treatment to chest of patient. in people with Covid19, run by Ward Photonics LLC at 1 site in United States.
Trial summary
To determine if a reduction of pneumonic inflammation occurs after treatment with Low-Level Laser Therapy (LLLT) applying red-light technology in the respiratory system of COVID-19 patients suffering from acute viral pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Non-invasive red LLLT treatment to chest of patient.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2021to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is diagnosed with COVID-19.
- Study participant is 18 years of age or older.
- Patient exhibiting moderate-to-acute respiratory distress.
Who cannot join
- Photosensitive condition or medication.
- Active chemotherapy treatment or other cancer treatment.
- Autoimmune Disorder.
- Pregnant, possibly pregnant or planning pregnancy prior to the end of study participation.
- Developmental disability or cognitive impairment that, in the opinion of the investigator, would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-Level Laser Therapy Treatment of Lung Inflammation in COVID-19 Patients
To determine if a reduction of pneumonic inflammation occurs after treatment with Low-Level Laser Therapy (LLLT) applying red-light technology in the respiratory system of COVID-19 patients suffering from acute viral pneumonia.
Read the detailed description
This clinical trial is a blinded before and after comparison of the effect on patients treated with a red-light LLLT therapy for acute lung inflammation as a result of COVID-19 infection. Patients are enrolled to undergo LLLT therapy in addition to all standard ongoing therapies for COVID-19.
Outcomes for patients receiving LLLT in addition to their standard care (the treatment group) are compared to the group receiving only standard therapy for COVID-19 (control group). Effects of LLLT treatment are measured immediately following treatment, and outcome measurements are compared to the pre-treatment baseline.
- Conditions
- Covid19
- Being tested
- Non-invasive red LLLT treatment to chest of patient., Sham Device Treatment
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive red LLLT treatment to chest of patient.Device
Expose patient to LLLT light while lying on their back, elevated at an angle of approximately 45 degrees from horizontal. Position light over the patient's chest at a 33-degree bias to their right and left sides for 20 minutes each side respectively.
Sham Device TreatmentDevice
Expose patient to sham device while lying on their back, elevated at an angle of approximately 45 degrees from horizontal. Position light over the patient's chest at a 33-degree bias to their right and left sides for 20 minutes each side respectively.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment Group | Experimental | LLLT Treatment using an UltraSlim red/IR LED device along with all standard treatment measures for COVID19. Receives: Device: Non-invasive red LLLT treatment to chest of patient. |
| Control Group | Sham comparator | Treatment using a Sham comparator along with all standard treatment measures for COVID19. Receives: Device: Sham Device Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation of the lungs - O2
Change in inflammation of the lungs as measured by O2 saturation levels
Measured: 10 days
Inflammation of the lungs - CRP
Change in inflammation of the lungs as measured by C-Reactive Protein (CRP) Test
Measured: 10 days
Inflammation of the lungs - IL6
Change in inflammation of the lungs as measured by IL-6 Levels
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start31 Jul 2021 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Why it stopped: Based upon feedback from IRB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blinded before and after comparison of COVID-19 patients treated with a red-light LLLT therapy in addition to standard treatment measures compared to a control group receiving only standard treatment measures.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ward Photonics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rober H Burke, MD, Principal investigator, Michigan Center for Cosmetic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524715
- Sponsor's protocol ID
- CP19-02
- Status last verified
- Jul 2022
- First submitted
- 19 Aug 2020
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This investigational study is exploratory in nature. The primary endpoint is most descriptive in statistical terms of whether the active patient group had significantly better outcomes than the control group. Individual patient data may be explored at a later date to determine related factors such as patient demographics, comorbidities, or other evidence of compounding variables.
Publications
Hamblin MR. Mechanisms and applications of the anti-inflammatory effects of photobiomodulation. AIMS Biophys. 2017;4(3):337-361. doi: 10.3934/biophy.2017.3.337. Epub 2017 May 19.
PubMed 28748217Rigonato-Oliveira NC, de Brito AA, Vitoretti LB, de Cunha Moraes G, Goncalves T, Herculano KZ, Alves CE, Lino-Dos-Santos-Franco A, Aimbire F, Vieira RP, Ligeiro de Oliveira AP. Effect of Low-Level Laser Therapy (LLLT) in Pulmonary Inflammation in Asthma Induced by House Dust Mite (HDM): Dosimetry Study. Int J Inflam. 2019 Mar 21;2019:3945496. doi: 10.1155/2019/3945496. eCollection 2019.
PubMed 31015955Gattinoni L, Chiumello D, Caironi P, Busana M, Romitti F, Brazzi L, Camporota L. COVID-19 pneumonia: different respiratory treatments for different phenotypes? Intensive Care Med. 2020 Jun;46(6):1099-1102. doi: 10.1007/s00134-020-06033-2. Epub 2020 Apr 14. No abstract available.
PubMed 32291463de Lima FM, Villaverde AB, Albertini R, Correa JC, Carvalho RL, Munin E, Araujo T, Silva JA, Aimbire F. Dual Effect of low-level laser therapy (LLLT) on the acute lung inflammation induced by intestinal ischemia and reperfusion: Action on anti- and pro-inflammatory cytokines. Lasers Surg Med. 2011 Jul;43(5):410-20. doi: 10.1002/lsm.21053.
PubMed 21674546Chen S, Li Y, Zheng Z, Luo Q, Chen R. The analysis of components that lead to increased work of breathing in chronic obstructive pulmonary disease patients. J Thorac Dis. 2016 Aug;8(8):2212-8. doi: 10.21037/jtd.2016.08.01.
PubMed 27621878Miranda da Silva C, Peres Leal M, Brochetti RA, Braga T, Vitoretti LB, Saraiva Camara NO, Damazo AS, Ligeiro-de-Oliveira AP, Chavantes MC, Lino-Dos-Santos-Franco A. Low Level Laser Therapy Reduces the Development of Lung Inflammation Induced by Formaldehyde Exposure. PLoS One. 2015 Nov 16;10(11):e0142816. doi: 10.1371/journal.pone.0142816. eCollection 2015.
PubMed 26569396da Cunha Moraes G, Vitoretti LB, de Brito AA, Alves CE, de Oliveira NCR, Dos Santos Dias A, Matos YST, Oliveira-Junior MC, Oliveira LVF, da Palma RK, Candeo LC, Lino-Dos-Santos-Franco A, Horliana ACRT, Gimenes Junior JA, Aimbire F, Vieira RP, Ligeiro-de-Oliveira AP. Low-Level Laser Therapy Reduces Lung Inflammation in an Experimental Model of Chronic Obstructive Pulmonary Disease Involving P2X7 Receptor. Oxid Med Cell Longev. 2018 Mar 4;2018:6798238. doi: 10.1155/2018/6798238. eCollection 2018.
PubMed 29686745Oliveira MC Jr, Greiffo FR, Rigonato-Oliveira NC, Custodio RW, Silva VR, Damaceno-Rodrigues NR, Almeida FM, Albertini R, Lopes-Martins RA, de Oliveira LV, de Carvalho Pde T, Ligeiro de Oliveira AP, Leal EC Jr, Vieira RP. Low level laser therapy reduces acute lung inflammation in a model of pulmonary and extrapulmonary LPS-induced ARDS. J Photochem Photobiol B. 2014 May 5;134:57-63. doi: 10.1016/j.jphotobiol.2014.03.021. Epub 2014 Apr 4.
PubMed 24792475
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Level Laser Therapy Treatment of Lung Inflammation in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04524715
- Acronym / sponsor ID
- CP19-02
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Based upon feedback from IRB.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ward Photonics LLCIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2021 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 24 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if a reduction of pneumonic inflammation occurs after treatment with Low-Level Laser Therapy (LLLT) applying red-light technology in the respiratory system of COVID-19 patients suffering from acute viral pneumonia.
Detailed description
This clinical trial is a blinded before and after comparison of the effect on patients treated with a red-light LLLT therapy for acute lung inflammation as a result of COVID-19 infection. Patients are enrolled to undergo LLLT therapy in addition to all standard ongoing therapies for COVID-19.
Outcomes for patients receiving LLLT in addition to their standard care (the treatment group) are compared to the group receiving only standard therapy for COVID-19 (control group). Effects of LLLT treatment are measured immediately following treatment, and outcome measurements are compared to the pre-treatment baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Blinded before and after comparison of COVID-19 patients treated with a red-light LLLT therapy in addition to standard treatment measures compared to a control group receiving only standard treatment measures.
| Arm | Type | Receives |
|---|---|---|
| Active Treatment Group | Experimental | Device: Non-invasive red LLLT treatment to chest of patient.LLLT Treatment using an UltraSlim red/IR LED device along with all standard treatment measures for COVID19. |
| Control Group | Sham comparator | Device: Sham Device TreatmentTreatment using a Sham comparator along with all standard treatment measures for COVID19. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant is diagnosed with COVID-19.
- Study participant is 18 years of age or older.
- Patient exhibiting moderate-to-acute respiratory distress.
Key exclusion criteria (5 listed)
- Photosensitive condition or medication.
- Active chemotherapy treatment or other cancer treatment.
- Autoimmune Disorder.
- Pregnant, possibly pregnant or planning pregnancy prior to the end of study participation.
- Developmental disability or cognitive impairment that, in the opinion of the investigator, would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive red LLLT treatment to chest of patient.Expose patient to LLLT light while lying on their back, elevated at an angle of approximately 45 degrees from horizontal. Position light over the patient's chest at a 33-degree bias to their right and left sides for 20 minutes each side respectively. | Device | Active Treatment Group |
| Sham Device TreatmentExpose patient to sham device while lying on their back, elevated at an angle of approximately 45 degrees from horizontal. Position light over the patient's chest at a 33-degree bias to their right and left sides for 20 minutes each side respectively. | Device | Control Group |
Primary outcome
Inflammation of the lungs - O2
Time frame: 10 days
Change in inflammation of the lungs as measured by O2 saturation levels
Inflammation of the lungs - CRP
Time frame: 10 days
Change in inflammation of the lungs as measured by C-Reactive Protein (CRP) Test
Inflammation of the lungs - IL6
Time frame: 10 days
Change in inflammation of the lungs as measured by IL-6 Levels
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Background: PubMed 28748217Hamblin MR. Mechanisms and applications of the anti-inflammatory effects of photobiomodulation. AIMS Biophys. 2017;4(3):337-361. doi: 10.3934/biophy.2017.3.337. Epub 2017 May 19.
- Background: PubMed 31015955Rigonato-Oliveira NC, de Brito AA, Vitoretti LB, de Cunha Moraes G, Goncalves T, Herculano KZ, Alves CE, Lino-Dos-Santos-Franco A, Aimbire F, Vieira RP, Ligeiro de Oliveira AP. Effect of Low-Level Laser Therapy (LLLT) in Pulmonary Inflammation in Asthma Induced by House Dust Mite (HDM): Dosimetry Study. Int J Inflam. 2019 Mar 21;2019:3945496. doi: 10.1155/2019/3945496. eCollection 2019.
- Background: PubMed 32291463Gattinoni L, Chiumello D, Caironi P, Busana M, Romitti F, Brazzi L, Camporota L. COVID-19 pneumonia: different respiratory treatments for different phenotypes? Intensive Care Med. 2020 Jun;46(6):1099-1102. doi: 10.1007/s00134-020-06033-2. Epub 2020 Apr 14. No abstract available.
- Background: PubMed 21674546de Lima FM, Villaverde AB, Albertini R, Correa JC, Carvalho RL, Munin E, Araujo T, Silva JA, Aimbire F. Dual Effect of low-level laser therapy (LLLT) on the acute lung inflammation induced by intestinal ischemia and reperfusion: Action on anti- and pro-inflammatory cytokines. Lasers Surg Med. 2011 Jul;43(5):410-20. doi: 10.1002/lsm.21053.
- Background: PubMed 27621878Chen S, Li Y, Zheng Z, Luo Q, Chen R. The analysis of components that lead to increased work of breathing in chronic obstructive pulmonary disease patients. J Thorac Dis. 2016 Aug;8(8):2212-8. doi: 10.21037/jtd.2016.08.01.
- Background: PubMed 26569396Miranda da Silva C, Peres Leal M, Brochetti RA, Braga T, Vitoretti LB, Saraiva Camara NO, Damazo AS, Ligeiro-de-Oliveira AP, Chavantes MC, Lino-Dos-Santos-Franco A. Low Level Laser Therapy Reduces the Development of Lung Inflammation Induced by Formaldehyde Exposure. PLoS One. 2015 Nov 16;10(11):e0142816. doi: 10.1371/journal.pone.0142816. eCollection 2015.
- Background: PubMed 29686745da Cunha Moraes G, Vitoretti LB, de Brito AA, Alves CE, de Oliveira NCR, Dos Santos Dias A, Matos YST, Oliveira-Junior MC, Oliveira LVF, da Palma RK, Candeo LC, Lino-Dos-Santos-Franco A, Horliana ACRT, Gimenes Junior JA, Aimbire F, Vieira RP, Ligeiro-de-Oliveira AP. Low-Level Laser Therapy Reduces Lung Inflammation in an Experimental Model of Chronic Obstructive Pulmonary Disease Involving P2X7 Receptor. Oxid Med Cell Longev. 2018 Mar 4;2018:6798238. doi: 10.1155/2018/6798238. eCollection 2018.
- Background: PubMed 24792475Oliveira MC Jr, Greiffo FR, Rigonato-Oliveira NC, Custodio RW, Silva VR, Damaceno-Rodrigues NR, Almeida FM, Albertini R, Lopes-Martins RA, de Oliveira LV, de Carvalho Pde T, Ligeiro de Oliveira AP, Leal EC Jr, Vieira RP. Low level laser therapy reduces acute lung inflammation in a model of pulmonary and extrapulmonary LPS-induced ARDS. J Photochem Photobiol B. 2014 May 5;134:57-63. doi: 10.1016/j.jphotobiol.2014.03.021. Epub 2014 Apr 4.
- Individual participant dataSharing planned: No. This investigational study is exploratory in nature. The primary endpoint is most descriptive in statistical terms of whether the active patient group had significantly better outcomes than the control group. Individual patient data may be explored at a later date to determine related factors such as patient demographics, comorbidities, or other evidence of compounding variables.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rober H Burke, MD principal investigator
Michigan Center for Cosmetic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive red LLLT treatment to chest of patient. in people with Covid19, run by Ward Photonics LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation of the lungs - O2 (time frame: 10 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04524715, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.